Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT00021502
Eligibility Criteria:
Determination of study eligibility will be made by the Investigator on the basis of the inclusion criteria listed below:
SIRS Inclusion Criteria
Patients with SIRS as characterized by two or more of the following conditions (worst values in a 24 hour period):
* Either respiratory rate \>/= 20 breaths/minute, partial pressure of arterial carbon dioxide (PaCO2) \</= 32 torr, or mechanical ventilation,
* Heart rate \>/= 90 beats/minute,
* Either hyperthermia \>/= 38 degrees C, or hypothermia \</= 36 degrees C or
* Either white blood cell (WBC) \>/= 12,000 cells/mm3, \</= 4,000 cells/mm3, or \>/= 10% immature (band) forms
Shock Inclusion Criteria Patients with adequate fluid resuscitation (PCWP \>/= 12mmHg) and with one or more conventional vasopressors (continuing up to the time of randomization) being used to treat hypotension (MBP \< 60 mmHg or SBP \< 90 mmHg). Patients cannot be entered if they have been in shock for more than 24 hours.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00021502
Study Brief:
Protocol Section:
NCT00021502